Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers

NCT ID: NCT00915239

Last Updated: 2009-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-10-31

Brief Summary

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The purpose of this study is to determine whether proton pump inhibitor (PPI) induced hypersecretion leads to acid related symptoms after treatment in healthy volunteers.

Detailed Description

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Treatment with proton pump inhibitors (PPI) has been shown to cause rebound hypersecretion of gastric acid. The clinical significance of this phenomenon is however unclear. This study aims to examine whether or not healthy volunteers, who over a relatively short period of time treated with a PPI, develop dyspeptic symptoms after cessation of therapy. Dyspeptic symptoms will be measured subjectively using a validated questionnaire, which is filled out each day. Gastric acid will be measured indirectly with measurement of acid secretion markers (Gastrin and chromogranin-A).

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Study Groups

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Pantoprazole

Group Type ACTIVE_COMPARATOR

Pantoprazole

Intervention Type DRUG

40 mg pantoprazole once daily for 28 days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

identical placebo once daily for 28 days

Interventions

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Pantoprazole

40 mg pantoprazole once daily for 28 days

Intervention Type DRUG

Placebo

identical placebo once daily for 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* 18-70 years of age
* Informed consent
* No prior history of any GI disorder

Exclusion Criteria

* Dyspeptic complaints
* H. pylori infection
* Ongoing treatment with pain-relieving medications (i.e., NSAID)
* Pregnancy or breast feeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sahlgrenska University Hospital

Locations

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Sahlgrenska Univeristy Hospital

Gothenburg, Gothenburg, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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SUS/KUS2

Identifier Type: -

Identifier Source: org_study_id

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